CDER Plans Pilot to Test Clinical Data Interchange Standard

The FDA is planning a small pilot program to test how it handles nonclinical study data submitted electronically in SEND 3.1 format — a Clinical Data Interchange Standards Consortium (CDISC) standard the agency has moved towards to gather more study data.

The submission of SEND nonclinical datasets “is expected to continue to increase in the future,” the agency said, adding that the pilot will evaluate the compliance of sample SEND 3.1 datasets submitted to CDER.

CDER is looking for a maximum of five program participants. The center will prioritize submissions that address the most significant differences between SENDIG 3.1 and the previous version.